Some considerations about biosimilar safety

8th Asian Biologics and Biosimilars Congress

Statement of the Problem: Biosimilar safety is an important step to be approved. Biosimilar safety is related with the adverse drug
reactions as a result of their pharmacological actions and immunogenicities. The purpose of this study is to describe some considerations
about biosimilar safety such as naming, immunogenicity, manufacturing, pharmacovigilance, interchangeability, labeling, preclinical
studies, clinical studies and post-approval studies.
Methodology & Theoretical Orientation: Naming of biosimilar is an important step to differentiate biosimilar from the reference
product as a part of safety. Biosimlars are proteins having capacity of inducing immune response that may be humoral or cellular. Small
manufacturing alterations in the source materials or production process of any biologic product may lead to changes in molecular
structure and potentially its biologic effects. Pharmacovigilance planning include efforts beyond post marketing spontaneous reporting
and designed for enhancing and expedite the biosimilar manufacturer’s acquisition of safety information. Biosimilars, to be approved
interchangeable, it must meet a higher standard by producing the same clinical result as the reference product in any given patient. The
labeling is important to decide whether a specific adverse event/safety issue for biosimilar is already identified as a risk or could be a
new potential safety issue. Preclinical studies used animal models to preliminarily assess toxicity, including immunogenicity. Clinical
studies include an assessment of immunogenicity and PK or pharmacodynamics (PD). Finally, the need for post-approval studies to
establish efficacy in indications was not studied during the approval process and long-term safety studies.
Findings: Biosimilar is a new pharmaceutical product and its safety approval is very important.
Conclusion & Significance: Naming of biosimilar is an important step for safety and immunogenicity study is important for safety
assessment. Biosimilars, to be approved interchangeable, must meet a higher standard and preclinical studies, clinical studies, postapproval
studies, must be achieved.
Recommendations: Reaching to unified name, standard definition for biosimilar and close guideline and demonstration of other
aspects about biosimilar safety is recommended.

Biography

Samer M Al-Hulu is an Assistant Professor of Microbiology, completed his PhD from Babylon University, College of Science, Iraq. He has published more than 14 papers in microbiology field. He trains at Ministry of Health at Laboratory of Babylon Maternity and Children Hospital. Currently, he is working at Al-Qasim Green University, College of Food Science, Iraq.